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Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 2,085 FDA drug recalls in 2013.

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DateProductReasonClassFirm
May 28, 2013 Amikacin 250mg/ml 2ml, Main Street Compounding Pharmacy, 126 East Main Street... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Double Therapy Inj. SS ML, Main Street Compounding Pharmacy, 126 East Main St... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Methylprednisolone Acetate 80mg 1ml, Main Street Compounding Pharmacy, 126 Ea... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Lipo Blast 50ml, Methionine 25mg, Inositol 50 mg, Choline 100mg, Methyl B-12.... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Marcaine .1%/NS 400ml-pump, Main Street Compounding Pharmacy, 126 East Main S... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 EDTA 150mg/ml 100ml, Main Street Compounding Pharmacy, 126 East Main Street, ... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 240 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Mai... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Sodium Tetradecyl Sulfate 2.0% 30ml, Main Street Compounding Pharmacy, 126 Ea... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Aminophylline 25mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main S... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 40,000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern,... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Glycolic 70% ph 1.8 - gel 60ml, Main Street Compounding Pharmacy, 126 East Ma... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Single Strength PGE1 20mcg/ml, Main Street Compounding Pharmacy, 126 East Mai... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 AMIC-12 with lido 10ml, Main Street Compounding Pharmacy, 126 East Main Stree... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Adenosine Monophosphate, 50mg/ml 30ml, Main Street Compounding Pharmacy, 126 ... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 15,000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern,... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Lipo Blast w/o adenosine,Methionine 25mg, Inositol 50 mg, Choline 100mg, Meth... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 300 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Mai... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Lincomycin 300mg, Main Street Compounding Pharmacy, 126 East Main Street, New... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 B-12 0.5ml prefilled syringe, Main Street Compounding Pharmacy, 126 East Main... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 290 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Mai... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Bacteriostatic Water 30ml, Main Street Compounding Pharmacy, 126 East Main St... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Methylcob 100mcg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Str... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Testosterone Pellets 200mg, Main Street Compounding Pharmacy, 126 East Main S... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Lipotropic 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newb... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Testosterone Cypionate 200mg/ml, 10ml Main Street Compounding Pharmacy, 126 E... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Lipo B (Mic w/B5/B6/B12+Lido), Main Street Compounding Pharmacy, 126 East Mai... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Mesotherapy, Main Street Compounding Pharmacy, 126 East Main Street, Newbern,... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Alprostadil 40mg, Main Street Compounding Pharmacy, 126 East Main Street, New... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 220 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Mai... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Testosterone Pellets 25mg, Main Street Compounding Pharmacy, 126 East Main St... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Testosterone Cypionate/Testosterone Propionate 250mg 10ml, Main Street Compou... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Mic w/B6/B12/Lido 50ml, Main Street Compounding Pharmacy, 126 East Main Stree... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Amikacin 500mg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, N... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 3000IU, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, ... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Sermorelin 3mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbe... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 5,000U, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, ... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 HCG 5000iu kit, Main Street Compounding Pharmacy, 126 East Main Street, Newbe... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Mitomycin 40mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbe... The firm received seven reports of adverse reactions in the form of skin abscesses potentially li... Class II Main Street Family Pharmacy, LLC
May 28, 2013 Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Sin... Failed Dissolution Specification; during stability testing Class II Teva Pharmaceuticals USA, Inc.
May 27, 2013 Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, P... Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under st... Class II Earthlabs, Inc. DBA Wise Woman Herbals
May 25, 2013 Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patie... Presence of Particulate Matter; single visible particulate was identified during a retain sample ... Class II Hospira Inc.
May 25, 2013 Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 ... Presence of Particulate Matter: Glass particulate matter was observed in a retention sample durin... Class I Fresenius Kabi USA, LLC
May 23, 2013 INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 m... Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is... Class II Indelicare LLC
May 23, 2013 INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine... Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is... Class II Indelicare LLC
May 21, 2013 Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Cont... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plast... Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for po... Class II Baxter Healthcare Corp.
May 21, 2013 Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dos... Failed Impurities/Degradation Specification Class III Fresenius Kabi USA, LLC
May 21, 2013 5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only,... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carto... Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which cou... Class II American Health Packaging
May 21, 2013 Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Bax... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.